Events

Rappel de Access Free T3 Reagent Kit (used in the diagnosis and monitoring of patients with thyroid disorders). An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00818-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-17
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00818-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Beckman coulter has determined through customer feedback and internal testing that the access free t3 reagent lots demonstrate an upward shift in patient results. the preliminary results indicate this upward shift may be related to a june 2015 formulation design change that was introduced to improve the access free t3 open reagent pack stability. the upward shift in patient test results, therefore, is expected to be maintained for all future lots. patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change. due to matrix differences, qc values may not demonstrate a shift.
  • Action
    Beckman Coulter is advising users to discontinue use of the affected product and either verify the current Free T3 references interval(s) are appropriate or adjust or establish new reference intervals(s). Use of the affected lots can be resumed once the reference intervals have been evaluated. A review of previously generated results and clinical notification is at the discretion of the Laboratory Director. This acrtion has been closed out on 16 June 2017.

Device

Access Free T3 Reagent Kit (used in the diagnosis and monitoring of patients with thyroid disorde...
  • Modèle / numéro de série
    Access Free T3 Reagent Kit (used in the diagnosis and monitoring of patients with thyroid disorders). An in vitro diagnostic medical device (IVD)Reference Number: A132422Multiple lot numbers affectedARTG Number: 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd